Recall Z-2726-2016
Hospira Inc. · initiated February 6, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
Codes / lots: List Number 20679. Serial numbers: 15441019, 15441020, 15441037, 15441044, 15441082, 15441093, 15441118, 15441226, 15441229, 15441230, 15441240, 15441241, 15441244, 15441246, 15441247, 15441249, 15441253, 15441256, 15441258, 15441260, 15441265, 15441266, 15441270, 15441271, 15441272, 15441275, 15441285, 15441303, 15441304, 15441315, 15441318, 15441321, 15441323, 15441325, 15441349, 15441350, 15441367, 15441369, 15441371, 15441372, 15441378, 15441395, 15441399, 15441405, 15441409, 15441411, 15441437, 15441458, 15441489, 15441492, 15441493, 15441502, 15441506, 15441508, 15441513, 15441515, 15441516, 15441520, 15441522, 15441524, 15441526, 15441528, 15441532, 15441533, 15441534, 15441535, 15441536, 15441554, 15441601, 15441604, 15441605, 15441610, 15441611, 15441615, 15441633, 15441637, 15441638, 15441649, 15441704, 15441765, 15441816, 15441839, 15441960, 15441966, 15442037, 15442062, 15442090, 15442124, 15442126, 15442157, 15442193, 15442197, 15442207, 15442235, 15442280, 15442304, 15442306, 15442327, 15442370, 15442401, 15442408, 15442417, 15442448, 15442457, 15442512, 15442544, 15442636, 15442663, 15442831, 15442838, 15442841, 15442893, 15442905, 15442920, 15442927, 15442961…
Reason for recall
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
FDA-determined cause: Nonconforming Material/Component
Action taken
Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.
Details
- Recall number
- Z-2726-2016
- Initiated
- February 6, 2013
- Posted by FDA
- September 6, 2016
- Terminated
- November 14, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 357,778 total
- Distribution
- United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2722-2016 Class II | Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2723-2016 Class II | Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2724-2016 Class II | Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2725-2016 Class II | Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2727-2016 Class II | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2728-2016 Class II | Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2729-2016 Class II | Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2730-2016 Class II | Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |